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Clinical Trials/NCT03737383
NCT03737383
Completed
Not Applicable

Treating Violence-related PTSD and Substance Risk in Low-income, Urban Adolescents

State University of New York at Buffalo1 site in 1 country21 target enrollmentDecember 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Posttraumatic Stress Disorder
Sponsor
State University of New York at Buffalo
Enrollment
21
Locations
1
Primary Endpoint
Posttraumatic Stress Disorder Checklist-Civilian Version
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This project will provide initial feasibility and efficacy data for the implementation of Narrative Exposure Therapy (NET) to urban, at-risk youth. Posttraumatic stress and substance use outcomes, as well as participant responses to the intervention, will be examined.

Detailed Description

The goal of the proposed study is to gather preliminary feasibility and efficacy data for an innovative intervention (Narrative Exposure Therapy: NET) to promote adolescent mental health related to interpersonal trauma (IPT). Among those at highest risk for interpersonal violence and its sequelae are youth from urban, low-resourced neighborhoods. Post-traumatic stress disorder (PTSD) is a common outcome associated with IPT. Substance misuse (SUB) is a frequent concomitant of PTSD. NET is a promising intervention to reduce PTSD symptoms and associated psychological distress, via the supported reconstruction (narrative telling) of the traumas. NET has a critical advantage over existing PTSD treatments in that it can be delivered in a brief format, in community settings where at-risk adolescents are likely to be found. Despite its promise in treating adolescent distress, NET has yet to be tested as an intervention for those who have interpersonal trauma-related PTSD. Further NET's influence on SUB has not been examined. Accordingly, the objective of this project is to conduct a pilot study (N=30) to estimate NET treatment effects on PTSD symptoms and SUB in IPT-exposed urban adolescents (ages 16-21). Both feasibility and preliminary efficacy data will be collected to serve as pilot work for a larger-scale NIH proposal. Recruitment and intervention will be set within community partners where the adolescents already are connected and are receiving social or psychological services. Outcome data will be collected at: (T0) Baseline, and at 1(T1), and 3 months (T2) follow-up assessments. Participant responses to the intervention will be assessed post-intervention. Change in PTSD, SUB will be estimated with effect sizes and inferential tests. Preliminary evidence of efficacy and feasibility will pave the way for further NET development to offer a patient-oriented, community-based, intervention that will promote adolescent mental health for those at greatest risk for health access and outcomes disparities.

Registry
clinicaltrials.gov
Start Date
December 1, 2017
End Date
August 31, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jennifer Read

Principal Investigator

State University of New York at Buffalo

Eligibility Criteria

Inclusion Criteria

  • Adolescents (ages 16-25),
  • Positive PTSD diagnosis (CAPS diagnosis)
  • Positive lifetime incidence of interpersonal violence-related trauma.

Exclusion Criteria

  • Actively suicidal with an immediate referral to the community agency crisis staff
  • Severe cognitive delay
  • Active psychosis

Outcomes

Primary Outcomes

Posttraumatic Stress Disorder Checklist-Civilian Version

Time Frame: through study completion, an average of 3 years

assessed via PTSD checklist. The minimum score for this measure is 0 while the maximum is 80. Higher scores indicate more severe PTSD symptoms.

Secondary Outcomes

  • Young Adult Alcohol Consequences Questionnaire (YAACQ)(through study completion, an average of 3 years)
  • Alcohol Use Disorders Identification Test (AUDIT)(through study completion, an average of 3 years)

Study Sites (1)

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